UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016815 |
|---|---|
| Receipt number | R000019523 |
| Scientific Title | Magnifying endoscopy with crystal violet staining in the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma |
| Date of disclosure of the study information | 2015/03/17 |
| Last modified on | 2019/02/11 12:23:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Magnifying endoscopy with crystal violet staining in the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma
Acronym
Magnifying endoscopy with crystal violet staining in the differential diagnosis of duodenal adenoma/carcinoma
Scientific Title
Magnifying endoscopy with crystal violet staining in the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma
Scientific Title:Acronym
Magnifying endoscopy with crystal violet staining in the differential diagnosis of duodenal adenoma/carcinoma
Region
| Japan |
Condition
Condition
Sporadic nonampullary duodenal adenoma/carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the efficacy of magnifying endoscopy with crystal violet staining in the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The accuracy of the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma by magnifying endoscopy with crystal violet staining (low-grade dysplasia or high-grade dysplasia/carcinoma)
Key secondary outcomes
The sensitivity, specificity, positive predictive value, and negative predictive value of the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma by magnifying endoscopy with crystal violet staining (low-grade dysplasia or high-grade dysplasia/carcinoma) and the relationship between these and patients background or lesions information
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent endoscopic resection of nonampurally duodenal lesions and confirmed diagnosis of adenoma/carcinoma with pathological diagnosis
Key exclusion criteria
Patients with polyposis syndrome or evaluated incompetent by doctors in attendance
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
Address
Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University (K1), 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL
043-226-2083
araim-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Maruoka |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL
043-226-2083
Homepage URL
maruoka-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/pdf/10.1177/2050640614548980
Number of participants that the trial has enrolled
Results
CV-ME does not have additional diagnostic value compared with NBI-ME in the diagnosis of sporadic nonampullary duodenal adenoma/carcinoma.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We perform a retrospective study for magnifying endoscopy with crystal violet staining in the differential diagnosis of sporadic nonampullary duodenal low-grade dysplasia or high-grade dysplasia/intramucosal carcinoma.
Management information
Registered date
| 2015 | Year | 03 | Month | 17 | Day |
Last modified on
| 2019 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019523
